Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor

NCT01600495 | Completed Phase 4 Results DMC

• 1 other identifier: FR259137
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction.

Conditions

Pain

Keywords

pain; electric stimulation; nervous; transcutaneous; humanized childbirth

Outcome Measures

Primary Outcomes (1)

• Classification of Pain During Labor by Visual Analogue Scale

  To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale. Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)

  30 minutes

Secondary Outcomes (3)

• Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia

  10 hours

• Duration From Start of Labor Until Birth

  10 hours

• Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.

  10 hours

Study Arms (2)

Experimental TENS

EXPERIMENTAL

TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm

Other: Experimental TENS

control Group

NO INTERVENTION

Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.

Interventions

Experimental TENS OTHER

Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).

Experimental TENS

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• primigravida
• literate
• A single fetus in vertex position
• Low-risk Pregnancy
• From 37 weeks of gestation
• Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage
• Labor in early spontaneous
• No use of medications during the study period
• Absence of cognitive or psychiatric problems
• Intact membranes
• No risk factors associated
• Who wish to participate and signed the informed consent

You may not qualify if:

• TENS procedure intolerance
• Use of any medication or procedure that promotes pain relief
• Use of pacemaker

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

centro de referência para a saúde da mulher Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (1)

• Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11.

  PMID: 26701166 DERIVED

Related Links

• VAN DER SPANK, J.T.; CAMBIER, D.C.; DE PAEPE, H.M.C.; DANNEELS, L.A.G.; WITVROUW, E.E.; BEERENS, L. Pain relief in labour by transcutaneous electrical nerve stimulation (TENS). Arch Gynecol Obstet, v.264, p.131-136 May 2000.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Alessandra Cristina Marcolin
• Organization: University of São Paulo.

dralemar@uol.com.br

Tel.: (16) 36022587

Study Officials

• Alessandra C Marcolin, Professor

  Faculty of Medicine of São Paulo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof Dra.

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: May 17, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: October 5, 2015
• Results First Posted: March 17, 2014

Record last verified: 2015-09

Locations

BR (1)